AI-powered software for breast density assessment gets FDA nod

A new technology for breast density assessment that can seamlessly integrate into a PACS system workflow is now available to U.S. radiologists following the FDA’s clearance of the DENSITAS|density solution.

“The current standard of care is to visually assess breast density. The problem with visual assessment is that it introduces wide variability in density assessments. One radiologist may call a women's density lower while another may call it higher,” Mohamed Abdolell, CEO of Densitas Inc. told HCB News. “A standardized method of density assessment is, therefore, critical if it is to be incorporated in cancer risk models, to ensure equitable service/care delivery.”

Clearance for the Canadian enterprise’s solution comes just a week after Wisconsin governor Scott Walker signed a bill that requires that patient-issued mammography reports include if a woman has dense breast tissue so that she may seek additional screening options.

The Badger State is the 35th to enact such a law, right behind Utah, Washington state and Florida, which also signed bills on the matter this year.

Integrating seamlessly with the clinical workflow, the zero-click multi-vendor-compatible software evaluates breast density in current and prior images of the same patient, generating automated density reports to be included and viewed in studies when mammograms are displayed on the radiologist's workstation.

With DENSITAS|density, reports are presented in an image tray that enables non-obtrusive and easy access for viewing, eliminating the need for the radiologist to sift through the report as part of the normal clinical workflow.

In providing a standard breast assessment, the DENSITAS|density solution enables radiologists to make more confident diagnoses and integrate breast density into risk-based models for population screenings.

“Risk models can be used to help to identify women at high risk who should be more closely followed, so that early detection enables targeted treatment,” Abdolell said. “Follow-up can be defined by modality or by frequency of screening visits. Early detection and treatment are associated with very high survival rates. Late stage detection is associated with very poor outcomes.”

The clearance of DENSITAS|density also coincides with recommendations by the American College of Radiology, encouraging women with a family history of breast cancer and dense breasts to undergo breast MR procedures, and those with dense breasts alone to undergo breast ultrasounds, due to the associated risk of cancer.

The FDA has also issued its intent to ensure women get the most up-to-date, relevant information on breast density as part of its 2018 goals.

DENSITAS|density was recently declared practical for use in breast cancer risk models by a group of researchers in the U.K., and was displayed earlier this month at the 2018 SBI/ACR Breast Imaging Symposium in Las Vegas.

The solution is the first in a series of follow-on products, and is cleared for clinical use in the U.S., Europe, Canada and Australia.